UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020801 |
|---|---|
| Receipt number | R000023993 |
| Scientific Title | A phase II study of FOLFIRINOX in patients with advanced biliary tract cancer |
| Date of disclosure of the study information | 2016/02/01 |
| Last modified on | 2022/08/03 22:31:18 |
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Basic information
Public title
A phase II study of FOLFIRINOX in patients with advanced biliary tract cancer
Acronym
FOLFIRINOX for advanced biliary tract cancer
Scientific Title
A phase II study of FOLFIRINOX in patients with advanced biliary tract cancer
Scientific Title:Acronym
FOLFIRINOX for advanced biliary tract cancer
Region
| Japan |
Condition
Condition
Biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the safety and the efficacy of FOLFIRINOX in patients with advanced biliary tract cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
Response rate, disease control rate,
overall survival, and safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
FOFIRINOX which is a combination chemotherapy of oxaliplatin, irinotecan, leucovorin, and fluorouracil will be given every 2 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) unresectable or recurrent biliary tract cancer
2) histologically or cytologically confirmed adenocarcinoma
3) no prior chemotherapy or radiation therapy
4) age of 20-75 years
5) an Eastern Cooperative Oncology Group PS of 0 or 1
6) at least one measurable lesion
7) adequate hematological, liver, and renal function (white blood cell count=> 10 000/mm3, neutrophil count=>2000/mm3, hemoglobin=>9.0 g/dL, platelet count=>100 000/mm3, aspartate transaminase and alanine transaminase <=2.5x upper limit of normal, total bilirubin <=1.2x upper limit of normal, Creatinine clearance =>50 ml/min).
8) written informed consent
Key exclusion criteria
1) synchronous or metachronous double cancer, excluding carcinoma in situ or intramucosal carcinoma cured by local treatment
2) allergy for contrast medium for CT and MRI
3) brain metastasis
4) blood transfusion, blood products, or hematopoietic growth factor preparations such as G-CSF within 7 days before enrollment
5) UGT genetic polymorphisms of homozygous UGT1A1*28 or UGT1A1*6 or heterozygous UGT1A1*6 and UGT1A1*28
6) apparent coelomic fluid (pleural effusion, ascites, or pericardial fluid)
7) serious concomitant diseases
8) abnormal findings in ECG
9) intestinal pneumonia
10) poorly controlled diabetes
11) diarrhea including watery stools within 3 days before enrollment
12) grade 2 or higher peripheral sensory neuropathy
13) active infection other than HBV or HCV
14) serious allergy
15) history of severe drug allergy
16) pregnant or lactating woman
17) disqualified for trial by principal investigator.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Yousuke |
| Middle name | |
| Last name | Nakai |
Organization
The University of Tokyo
Division name
Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine,
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
naminatsu.takahara@gmail.com
Public contact
Name of contact person
| 1st name | Naminatsu |
| Middle name | |
| Last name | Takahara |
Organization
The University of Tokyo
Division name
Department of Gastroenterology, Graduate School of Medicine,
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
naminatsu.takahara@gmail.com
Sponsor or person
Institute
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (grant number 2018-2020)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo, Clinical Research Review Board
Address
7-3-1, Hongo,Bunkyo-ku,Tokyo, Tokyo
Tel
03-5841-0818
mgr-ohrs@m.u-tokyo.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCTs 031180082
Org. issuing International ID_1
Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京大学医学部附属病院（東京都）、京都大学病院(京都府)、大阪国際がんセンター(大阪府)、がん研有明病院(東京都)、杏林大学（東京都）、順天堂大学順天堂医院(東京都)、国立がん研究センター中央病院(東京都)、国立がん研究センター東病院(千葉県)、神奈川県立がんセンター(神奈川県)、徳島大学病院(徳島県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 29 | Day |
Last modified on
| 2022 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023993
